Update to the guidance document “RMP ICH E2E Information for submission HMP” valid from 1 July 2025

The guidance document RMP ICH E2E Information for submission HMP has been thoroughly revised and clarified in editorial and technical terms. The following topics in particular are affected:

Training material: Training material is now referred to as educational material. At the same time, it is defined and described what is to be understood as officially ordered educational material and how it must be labelled. From July 1, 2025, the labelling of educational materials ordered by the authorities for the first time with the “Blue Safety Information” symbol will be mandatory. A transitional period applies to educational materials already ordered (until the next revision of the materials, but no later than June 30, 2026).
RMP for Art. 13 TPA submissions: With immediate effect, the latest RMP approved by the reference authority must be submitted in Module 1.8.2 for authorizations under Art. 13 TPA. If the FDA is the reference authority, an RMP must also be submitted in the Swiss Module 1.8.2 (preferably the approved EU RMP).
“Standalone” RMP applications: “Standalone” RMPs, if they are EU RMPs, should always be submitted to Swissmedic only after approval by the EMA.

The amended guidance document has been valid since 01.07.2025.

Updated Guideline "RMP ICH E2E – Information Submission HAM"

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